The Spire Hospital Bristol, The Glen, Durdham Down, Bristol BS6 6UT Tel: 0117 968 8144

Textured Breast Implants

Important Notice

Mr Lee has always used and will only use high quality implants that carry a current European safety certificate.

Statement Regarding the withdrawal of CE safety certificate of Allergan textured implants

Textured implant controversy

You have probably heard that Allergan had its European safety licence not-renewed this month for its textured breast implants. If you are an existing or historic patient I am very sorry for any worry or anxiety that recent news has caused you, however I do not think you need to worry or take any action at the moment.

Marc Pacifico from The British Association of Aesthetic Plastic Surgeons said this in summary

“The majority of patients in the UK with breast implants will have textured surface implants in their breasts. According to all the latest scientific data these remain safe devices and there is no indication for any women to consider removing or replacing their implants..”

I have used Allergan textured implants for all my patients since becoming a consultant. I have no affiliation and never have had with Allergan however I have always used these implants because they have been widely regarded as the best on the market and have come with a life time warranty against rupture.

Allergan has now lost its safety licence to make and sell its textured implants in Europe. This is because a certain type of lymphoma, ALCL (Anaplastic Large Cell Lymphoma) has been observed in some patients who have had textured breast implants. (Not all by Allergan) This number is extremely small and not everybody agrees there is any association with a textured breast implant.

No leading authority or government regulatory body are recommending that these implants be removed. This would also carry risk.

Here are some facts that may help explain things better and reassure you.

Breast Implant Associated – Anaplastic Large Cell Lymphoma (BIA-ALCL) usually causes swelling in your breast. If discovered it is usually completely treatable with a simple operation to remove the implant capsule and change your implants.

It is the French regulatory authorities that have stepped in to withhold the CE safety marking. Not all regulatory authorities at this time feel that this is necessary. For example the FDA in America has not made a similar decision. The FDA is usually much tougher on safety standards than the European counterpart (CE)

I have seen risk figures quoted as low as 1 in 300 000 and as high as 1 in 25 000. (Lifetime exposure per implant) To compare this an operation and general anaesthetic also has risks including stroke, heart attack, chest infection, drug allergy (anaphylaxis), or thrombo-embolism. Taking thrombo-embolism alone the estimated risk of a significant (and therefore life threatening) deep vein thrombosis or pulmonary embolism is about 1 in 10 000 for cosmetic breast surgery and 2 in 1000 for some cosmetic trunk procedures. (ASAPS Journal 2017) The annual risk of dying in a road traffic accident in the UK is 1 in 20 000 or a lifetime risk of 1 in 240. (1 in 80 in the Ukraine!) (Bandolier)

Here is what the UK regulator MHRA (Medicines and Healthcare Products Regulatory Agency Gov.UK) says

“ We are aware Allergan have stopped selling textured breast implants and tissue expanders and intend to withdraw remaining supply in European markets.

There is currently no evidence of an increased risk to patients and there is no need for people who have Allergan breast implants to get them removed or have any additional clinical follow-up.

We are monitoring the situation closely and will provide updates as necessary.”

 

Allergan are a widely respected multinational and multi brand organisation who have produced and developed some very useful drugs and technologies. Here is what they have written to its customers to say.

“ Allergan is reaching out to you to notify you of an issue regarding the availability of our textured breast implants in the UK.

Effective immediately, Allergan is suspending sales of textured breast implants and tissue expanders and withdrawing any remaining supply in European markets. The withdrawal decision follows a compulsory recall request from Agence Nationale de Sécurité du Médicament (ANSM), the French regulatory authority. The suspension of sales stems from the expiration of the company’s CE Mark for these products.

Although Allergan disagrees with ANSM’s request, the Company is fully cooperating with the authority. Allergan stands behind the benefit/risk profile of our breast implant products. The ANSM request, and this action, is not based on any new scientific evidence. Furthermore, ANSM has not identified any immediate risk to the health of women with textured breast implants.

Capsular contraction rate (hardening of the implant) by experimenting with different grades of texturing on the implant surface. Reducing the capsular contraction rate prevents you from having to go through surgery again to revise your breast augmentation. Bringing down both the risk and cost to you.”

 

Once again I am sorry for any anxieties or fears caused by the above news. However I do not think you need to take any action or worry. If you have a recurrently swollen or painful breast you should make a follow up appointment to see me. This is no different to previous advice.

Yours Sincerely

Simon Lee MBBS MSc FRCS Gen Surg FRCS Plastics

Consultant Plastic surgeon

 

 

Queries

If you have any queries please contact us using one of the following methods:

Email: mrlee@simonleefrcs.co.uk

Telephone:
Tel: 0117 968 8144
Mobile: 07809 775 621

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